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Standards Development: Consensus Method for Rating 0.1 Mycoplasma Reduction Filters (New Standard)

Type:
  • Standards Development
Application Deadline: 13 Sep, 2019
Location:
  • Virtual
  • In Person
Bethesda, Maryland
Openings: 20

Description

PDA is very pleased to announce the launch of the Parenteral Drug Association’s fifth standard!  We are seeking volunteer participants to assist in developing, writing, and fine tuning the following proposal: Consensus Method for Rating 0.1 Mycoplasma Reduction Filters (new standard).

Scope

The plan is to base the standard off an existing PDA technical report, TR #75, in order to facilitate standardization of 0.1 µm filter claims for mycoplasma clearance and allow a more effective comparison of mycoplasma removal efficiency by a wide range of filters.

This proposed American National Standard (ANS) was presented by Ms. Martha Folmsbee, Principal Staff Scientist at Pall Corporation.

Those individuals involved in:

  • Filter Manufacturing
  • Filter end-users (both sterilizing-grade and non-sterilizing-grade)
  • Plasma derived product manufacturers,
  • and regulators are being sought

Who Should Apply

Nominations/Volunteers to serve as a member of the technical team (consensus body) must have some subject matter expertise, and willing to help write/contribute to this standard. Applicants should apply by contacting the PDA Standards Manager

Skills

  • Project Management
  • Technical Writing/Editing
  • Biotech
  • Quality & Compliance
  • Sterile Processing
  • Regulatory Affairs

Requirements

  • CV
  • *Completed contact form 

*The contact form will be provided by the PDA Standards Manager at [email protected].